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JETREA
Overview
What is JETREA?
Ocriplasmin is a recombinant truncated form of human plasmin with a molecular weight of 27.2 kDa produced by recombinant DNA technology in a expression system.
JETREA is a sterile, clear and colorless solution with no preservatives in a single-use glass vial containing 0.375 mg ocriplasmin in 0.3 mL solution for intravitreal injection.
Each vial contains 0.375 mg ocriplasmin (active), 0.16 mg citric acid, 0.56 mg mannitol, 1.35 mg sodium chloride, sodium hydroxide and hydrochloric acid (for pH adjustment), and water for injection (q.s.). The pH of the solution is 3.1.
What does JETREA look like?
What are the available doses of JETREA?
Injection: Single-use glass vial containing JETREA 0.375 mg in 0.3 mL solution for intravitreal injection (1.25 mg/mL). ()
What should I talk to my health care provider before I take JETREA?
How should I use JETREA?
JETREA is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion.
For single-use ophthalmic intravitreal injection only. JETREA must only be administered by a qualified physician.
This formulation of JETREA does not require dilution.
What interacts with JETREA?
Sorry No Records found
What are the warnings of JETREA?
Sorry No Records found
What are the precautions of JETREA?
Sorry No Records found
What are the side effects of JETREA?
Sorry No records found
What should I look out for while using JETREA?
None
What might happen if I take too much JETREA?
The clinical data on the effects of JETREA overdose are limited. One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) was reported to be associated with inflammation and a decrease in visual acuity.
How should I store and handle JETREA?
Each vial of JETREA contains 0.375 mg ocriplasmin in 0.3 mL preservative-free, citric-buffered solution (1.25 mg/mL). JETREA is supplied in a 2 mL glass vial with a blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex. Vials are for single use only.NDC 24856-002-01StorageStore frozen at or below -4°F (-20°C). Protect the vials from light by storing in the original package until time of use.Each vial of JETREA contains 0.375 mg ocriplasmin in 0.3 mL preservative-free, citric-buffered solution (1.25 mg/mL). JETREA is supplied in a 2 mL glass vial with a blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex. Vials are for single use only.NDC 24856-002-01StorageStore frozen at or below -4°F (-20°C). Protect the vials from light by storing in the original package until time of use.Each vial of JETREA contains 0.375 mg ocriplasmin in 0.3 mL preservative-free, citric-buffered solution (1.25 mg/mL). JETREA is supplied in a 2 mL glass vial with a blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex. Vials are for single use only.NDC 24856-002-01StorageStore frozen at or below -4°F (-20°C). Protect the vials from light by storing in the original package until time of use.Each vial of JETREA contains 0.375 mg ocriplasmin in 0.3 mL preservative-free, citric-buffered solution (1.25 mg/mL). JETREA is supplied in a 2 mL glass vial with a blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex. Vials are for single use only.NDC 24856-002-01StorageStore frozen at or below -4°F (-20°C). Protect the vials from light by storing in the original package until time of use.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ocriplasmin has proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen), thereby dissolving the protein matrix responsible for the vitreomacular adhesion (VMA).
Non-Clinical Toxicology
NoneInhibitors of CYP2D6
The concomitant use of tramadol and CYP2D6 inhibitors, such as quinidine, fluoxetine, paroxetine and bupropion, may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol is achieved. Since M1 is a more potent µ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol. Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome.
After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase which could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity, and may cause potentially fatal respiratory depression (see )
If concomitant use of a CYP2D6 inhibitor is necessary, follow patients closely for adverse reactions including opioid withdrawal, seizures, and serotonin syndrome.
If a CYP2D6 inhibitor is discontinued, consider lowering tramadol dosage until stable drug effects are achieved. Follow patients closely for adverse events including respiratory depression and sedation.
Use With Quinidine
Quinidine is a selective inhibitor of CYP2D6, so that concomitant administration of quinidine and tramadol results in increased concentrations of tramadol and reduced
concentrations of M1. The clinical consequences of these findings are unknown.
Inhibitors of CYP3A4
The concomitant use of tramadol and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir), can increase the plasma concentration of tramadol, and may result in a greater amount of metabolism via CYP2D6 and greater levels of M1. Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when a CYP3A4 inhibitor is added after a stable dose of tramadol is achieved.
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease (see ), resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to tramadol.
If concomitant use is necessary, consider dosage reduction of tramadol until stable drug effects are achieved. Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the tramadol dosage until stable drug effects are achieved and follow patients for signs and symptoms of opioid withdrawal.
CYP3A4 Inducers
The concomitant use of tramadol and CYP3A4 inducers, such as rifampin, carbamazepine and phenytoin, can decrease the plasma concentration of tramadol resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol (see ).
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures and serotonin syndrome, and potentially fatal respiratory depression.
Use With Carbamazepine
Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol and carbamazepine is not recommended.
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Examples of other CNS depressants include other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, and some illicit drugs.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit the treatment to the minimum effective dosages and durations. Follow patients closely for signs of respiratory depression and sedation (see ).
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone), monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue tramadol immediately if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
Do not use tramadol in patients taking MAOIs or within 14 days of stopping such treatment.
MAOI interactions with opioids may manifest as serotonin syndrome (see ) or opioid toxicity (e.g., respiratory depression, coma) (see ). Examples of these drugs include, phenelzine, tranylcypromine, linezolid.
Digoxin
Post-marketing surveillance has revealed rare reports of digoxin toxicity. Follow patients for signs of digoxin toxicity and adjust dosage of digoxin as needed.
Warfarin
Post-marketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times. Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Mixed agonist/antagonist and partial agonist opioid analgesics may reduce the analgesic effect of tramadol and/or precipitate withdrawal symptoms. Examples of these drugs include butorphanol, nalbuphine, pentazocine and buprenorphine. Avoid concomitant use of these drugs.
Muscle Relaxants
Tramadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of tramadol and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility when tramadol is used concomitantly with anticholinergic drugs.
A decrease of ≥ 3 line of best corrected visual acuity (BCVA) was experienced by 5.6% of patients treated with JETREA and 3.2% of patients treated with vehicle in the controlled trials ].
The majority of these decreases in vision were due to progression of the condition with traction and many required surgical intervention. Patients should be monitored appropriately .
The following adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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